ID

17761

Beskrivning

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK A 24 week double-blind, randomized, placebo-controlled, parallel-group dose-raging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer´s disease. Medicine: rosiglitazone, Condition: Alzheimer´s Disease, Phase: 2, Clinical Study ID: AVA 100193, Sponsor: GSK. This ODM contains the Early Withdrawal.

Nyckelord

  1. 2016-10-03 2016-10-03 -
  2. 2016-12-09 2016-12-09 -
Uppladdad den

3 oktober 2016

DOI

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Creative Commons BY-NC 3.0

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NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Early Withdrawal

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Early Withdrawal

General Information
Beskrivning

General Information

Protocol Identifier: AVA100193
Beskrivning

Protocol Identifier

Datatyp

boolean

Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Visit Date
Beskrivning

Visit Date

Datatyp

date

Visit Description: Early Withdrawal
Beskrivning

Visit Description

Datatyp

boolean

Instructions
Beskrivning

Instructions

Instructions completed
Beskrivning

Instructions completed

Datatyp

boolean

Vital signs
Beskrivning

Vital signs

Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
kg
Blood pressure: systolic
Beskrivning

Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.

Datatyp

integer

Blood pressure: diastolic
Beskrivning

Blood pressure

Datatyp

integer

Måttenheter
  • mmHg
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
bpm
Central Laboratory (Non Fasting Samples)
Beskrivning

Central Laboratory (Non Fasting Samples)

Date samples taken
Beskrivning

Date samples taken

Datatyp

date

Pregnancy test: pregnant
Beskrivning

If subject is female and of childbearing potential a serum pregnancy test must be performed.

Datatyp

boolean

Concomitant Medications
Beskrivning

Concomitant Medications

Concomitant Medications
Beskrivning

Concomitant Medications

Datatyp

text

Adverse Events
Beskrivning

Adverse Events

Non-Serious Adverse Events/Serious Adverse Events
Beskrivning

Non-Serious Adverse Events/Serious Adverse Events

Datatyp

text

Physical Examination
Beskrivning

Physical Examination

Results from Physical Examination
Beskrivning

Results from Physical Examination

Datatyp

text

Pedal Oedema
Beskrivning

Pedal Oedema

Depth of Indentation
Beskrivning

Depth of Indentation

Datatyp

text

Indicate which ankle was assessed at this visit
Beskrivning

Ankle

Datatyp

text

Further Instructions
Beskrivning

Further Instructions

Instructions followed and next visit scheduled?
Beskrivning

Instructions followed and next visit scheduled?

Datatyp

boolean

Similar models

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Early Withdrawal

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
General Information
Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
Subject Identifier
Item
Subject Identifier
integer
Visit Date
Item
Visit Date
date
Visit Description
Item
Visit Description: Early Withdrawal
boolean
Item Group
Instructions
Instructions completed
Item
Instructions completed
boolean
Item Group
Vital signs
Weight
Item
Weight
float
Blood pressure
Item
Blood pressure: systolic
integer
Blood pressure
Item
Blood pressure: diastolic
integer
Heart rate
Item
Heart rate
integer
Item Group
Central Laboratory (Non Fasting Samples)
Date samples taken
Item
Date samples taken
date
Pregnancy test
Item
Pregnancy test: pregnant
boolean
Item Group
Concomitant Medications
Concomitant Medications
Item
Concomitant Medications
text
Item Group
Adverse Events
Non-Serious Adverse Events/Serious Adverse Events
Item
Non-Serious Adverse Events/Serious Adverse Events
text
Item Group
Physical Examination
Results from Physical Examination
Item
Results from Physical Examination
text
Item Group
Pedal Oedema
Item
Depth of Indentation
text
Code List
Depth of Indentation
CL Item
< 1 mm (1)
CL Item
1-2 mm (2)
CL Item
3-5 mm (3)
CL Item
6-10 mm (4)
CL Item
> 10 mm (5)
Item
Indicate which ankle was assessed at this visit
text
Code List
Indicate which ankle was assessed at this visit
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Item Group
Further Instructions
Instructions followed and next visit scheduled?
Item
Instructions followed and next visit scheduled?
boolean

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